United States - English - NLM (National Library of Medicine)

b. braun medical inc. - hydroxyethyl starch 130/0.4 (unii: 1gvo236s58) (hydroxyethyl starch 130/0.4 - unii:1gvo236s58), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - hydroxyethyl starch 130/0.4 6 g in 100 ml - 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection is indicated for the treatment and prophylaxis of hypovolemia in adults and children. it is not a substitute for red blood cells or coagulation factors in plasma. - do not use hydroxyethyl starch (hes) products, including 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (rrt).  - do not use hes products, including 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, in patients with severe liver disease. - do not use hes products, including 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, in patients with known hypersensitivity to hydroxyethyl starch [see general warnings and precautions (5.1) ] - do not use hes products in clinical conditions with volume overload.  - do not use hes products in patients with pre-existing coagulation or bleeding disorders.  - do not use h

United States - English - NLM (National Library of Medicine)

b. braun medical inc. - hetastarch (unii: 875y4127ea) (hetastarch - unii:875y4127ea), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - hetastarch 6 g in 100 ml - hespan® is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. it is not a substitute for blood or plasma. the adjunctive use of hespan® in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. - do not use hes products, including hespan®, unless adequate alternative treatment is unavailable. hetastarch has been shown to have an embryocidal effect on new zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 ml) and on bd rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. when hetastarch was administered to new zealand rabbits, bd rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the m

United States - English - NLM (National Library of Medicine)

hospira, inc. - hetastarch (unii: 875y4127ea) (hetastarch - unii:875y4127ea) - 6% hetastarch in 0.9% sodium chloride injection is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. it is not a substitute for blood or plasma. the adjunctive use of 6% hetastarch in 0.9% sodium chloride injection in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. do not use hes products, including 6% hetastarch in 0.9% sodium chloride injection, unless adequate alternative treatment is unavailable. hetastarch has been shown to have an embryocidal effect on new zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 ml) and on bd rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. when hetastarch was administered

United States - English - NLM (National Library of Medicine)

hospira, inc. - hetastarch (unii: 875y4127ea) (hetastarch - unii:875y4127ea) - hetastarch 6 g in 100 ml

United States - English - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - hetastarch (unii: 875y4127ea) (hetastarch - unii:875y4127ea) - 6% hetastarch in 0.9% sodium chloride injection is indicated in the treatment of hypovolemia when plasma volume expansion is desired. it is not a substitute for blood or plasma. the adjunctive use of 6% hetastarch in 0.9% sodium chloride injection in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. do not use hydroxyethyl starch (hes) products, including 6% hetastarch in 0.9% sodium chloride injection, in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (rrt). • do not use hes products, including 6% hetastarch in 0.9% sodium chloride injection, in patients with severe liver disease • do not use hes products, including 6% hetastarch in 0.9% sodium chloride injection, in patients with known hypersensitivity to hydroxyethyl starch • do not use hes products, including 6% hetastarch in 0.9% sodium chloride injection, in clinical conditions where volume overload is a potential problem (such as, congestive heart failure or renal disease with anuria or oliguria not related to hypovolemia). • do not use hes products, including 6% hetastarch in 0.9% sodium chloride injection, in patients with pre-existing coagulation or bleeding disorders 8.1 pregnancy hetastarch has been shown to have an embryocidal effect on new zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 ml) and on bd rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. when hetastarch was administered to new zealand rabbits, bd rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident. there are no adequate and well-controlled studies in pregnant women. 6% hetastarch in 0.9% sodium chloride injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 nursing mothers it is not known whether hetastarch is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when 6% hetastarch in 0.9% sodium chloride injection is administered to a nursing woman. 8.4 pediatric use the safety and effectiveness of hetastarch in pediatric patients have not been established. adequate, well-controlled clinical trials to establish the safety and effectiveness of 6% hetastarch in 0.9% sodium chloride injection in pediatric patients have not been conducted.

New Zealand - English - Medsafe (Medicines Safety Authority)

paragon care group new zealand limited t/a rem systems - hetastarch 6% (molar substitution 0.7, av. mwt 480,000 daltons);  ; sodium chloride 0.9% - solution for infusion - active: hetastarch 6% (molar substitution 0.7, av. mwt 480,000 daltons)   sodium chloride 0.9% excipient: water for injection

Australia - English - Department of Health (Therapeutic Goods Administration)

global medical solutions australia pty limited t/a radpharm scientific - sodium oxidronate, quantity: 3.15 mg - injection, powder for - excipient ingredients: sodium chloride; stannous chloride dihydrate; dilute hydrochloric acid; gentisic acid; sodium hydroxide - technetium [99m tc] sodium oxidronate is a diagnostic skeletal imaging agent to demonstrate areas of altered osteogenesis in adult patients.

United States - English - NLM (National Library of Medicine)

hospira, inc. - hydroxyethyl starch 130/0.4 (unii: 1gvo236s58) (hydroxyethyl starch 130/0.4 - unii:1gvo236s58) - hydroxyethyl starch 130/0.4 6 g in 100 ml - voluven ® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia in adults and children. it is not a substitute for red blood cells or coagulation factors in plasma. - do not use hydroxyethyl starch (hes) products, including voluven ® , in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (rrt). - do not use hes products, including voluven ® , in patients with severe liver disease. - do not use hes products, including voluven ® , in patients with known hypersensitivity to hydroxyethyl starch [see general warnings and precautions (5.1) ] - do not use hes products in clinical conditions with volume overload. - do not use hes products in patients with pre-existing coagulation or bleeding disorders. - do not use hes products in patients with renal failure with oliguria or anuria not related

United States - English - NLM (National Library of Medicine)

cardinal health - hetastarch (unii: 875y4127ea) (hetastarch - unii:875y4127ea) - hetastarch 6 g in 100 ml

Australia - English - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - hydroxyethyl starch 130/0.4, quantity: 60 g/l - injection, solution - excipient ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide - treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient. the use of voluven is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma.